Brochure
Enquire- Introduction to Clinical Research
- Terminologies in Clinical Research
- Advantages of CR in India
- Introduction to Clinical Research- Notes
- Introduction to Clinical Research Quiz
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- TechnoBridge
- Courses
- Best Clinical Data Management Courses in Pune
Online
2 Months
₹ 23,000
Quick facts
| particular | details | |
|---|---|---|
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Medium of instructions
English
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Mode of learning
Self study, Virtual Classroom
+1 more
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Mode of Delivery
Video and Text Based
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Course and certificate fees
Fees information
₹ 23,000
certificate availability
Yes
certificate providing authority
TechnoBridge
The syllabus
Module 1 - Introduction to Clinical Research
Module 2 -Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
Module 3 - Pharmacovigilance
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unblinding of Drug
- Clinical Safety and Pharmacovigilance
- E2A- Clinical Safety and Data Management
- Media 436
- Naranjo Assessment
- Order and Formulate to Determine the Quantum
Module 4 - Drug Development Process
- Overview of Drug Development
- Clinical trial phases
- BA/BE Studies
- Drug Development Notes
- Drug Development Quiz
Module 5 - Clinical Data Management
- CFR Part 11
- CRF_Design_2
- Introduction to CDM
- Data Entry Methods
- Query Management
- Source data validation
- Future of Data Management
Module 6 - Regulatory Affairs
- Application of Permission
- Approval of Clinical Trial
- CDSCO
- Code of Federal Regulation (CFR)
- CT_Rules_2019
- ICMR Guidelines
- Medical Devices
- ICMR Guidelines
- DoH Oct 2013
- Guidelines for Industry
